{"schemaVersion":"jobsearcher.job.v1","id":"930fa0f823d44b8329d92d07","url":"https://jobsearcher.com/jobs/930fa0f823d44b8329d92d07","canonicalUrl":"https://jobsearcher.com/jobs/930fa0f823d44b8329d92d07","title":"Validation Engineer II","description":"Summary\nThe Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. This resource has to ensure compliance with industry standards and regulatory requirements while working closely with cross‑functional teams to support new installations, system upgrades, and operational readiness.\n\nRoles & Responsibilities\n\nPlan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed gases) and facilities (e.g., cleanrooms, environmental monitoring systems).\n\nTroubleshoot and resolve technical issues during the commissioning phase.\n\nAuthor, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.\n\nValidate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.\n\nEnsure systems meet performance requirements and GMP standards.\n\nPerform thermal mapping, pressure testing, and other critical tests as needed.\n\nDevelop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.\n\nDocument deviations, CAPAs, and change controls associated with facilities and utilities systems.\n\nEnsure traceability of qualification activities in alignment with the Validation Master Plan (VMP).\n\nEnsure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).\n\nPerform risk assessments and develop mitigation strategies for utility and facility systems.\n\nEnsure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.\n\nEducation & Experience\n\n3–5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.\n\nHands‑on experience with systems such as HVAC, purified water, clean steam, gases, and cleanrooms.\n\nKneat experience\n\nFamiliarity with environmental monitoring and building management systems (Client).\n\nManufacturing plant and utility environments, including cleanrooms.\n\nFlexibility to work extended hours or weekends during critical project phases.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Houston","state":"TX","isRemote":false,"isActive":false,"createdAt":"2026-07-08T03:18:30.829Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer II","description":"Summary\nThe Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. This resource has to ensure compliance with industry standards and regulatory requirements while working closely with cross‑functional teams to support new installations, system upgrades, and operational readiness.\n\nRoles & Responsibilities\n\nPlan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed gases) and facilities (e.g., cleanrooms, environmental monitoring systems).\n\nTroubleshoot and resolve technical issues during the commissioning phase.\n\nAuthor, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.\n\nValidate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.\n\nEnsure systems meet performance requirements and GMP standards.\n\nPerform thermal mapping, pressure testing, and other critical tests as needed.\n\nDevelop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.\n\nDocument deviations, CAPAs, and change controls associated with facilities and utilities systems.\n\nEnsure traceability of qualification activities in alignment with the Validation Master Plan (VMP).\n\nEnsure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).\n\nPerform risk assessments and develop mitigation strategies for utility and facility systems.\n\nEnsure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.\n\nEducation & Experience\n\n3–5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.\n\nHands‑on experience with systems such as HVAC, purified water, clean steam, gases, and cleanrooms.\n\nKneat experience\n\nFamiliarity with environmental monitoring and building management systems (Client).\n\nManufacturing plant and utility environments, including cleanrooms.\n\nFlexibility to work extended hours or weekends during critical project phases.\n\n#J-18808-Ljbffr","datePosted":"2026-07-08T03:18:30.829Z","dateModified":"2026-07-08T03:18:30.829Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Houston","addressRegion":"TX","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"930fa0f823d44b8329d92d07"},"url":"https://jobsearcher.com/jobs/930fa0f823d44b8329d92d07"}}